Evaluating brain mechanisms of combined vagus nerve stimulation and mindfulness training for migraine: A randomized 2 × 2 factorial clinical trial protocol.

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Title: Evaluating brain mechanisms of combined vagus nerve stimulation and mindfulness training for migraine: A randomized 2 × 2 factorial clinical trial protocol.
Authors: Schuman-Olivier Z; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA. Electronic address: zschuman@cha.harvard.edu., Marin F; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA., Kinder LD; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA., Datko M; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA., Round K; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA., Tohyama S; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA., Garcia RG; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; School of Medicine, Universidad de Santander, Bucaramanga, Colombia., Hirschtick RL; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Edwards RR; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Wells RE; Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, NC, USA., Cheng HT; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Barbieri R; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Hadjikhani N; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Loggia ML; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Kaptchuk TJ; Department of Medicine, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA, USA., Houle TT; Department of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Rosen BR; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Napadow V; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Source: Contemporary clinical trials [Contemp Clin Trials] 2025 Jul; Vol. 154, pp. 107947. Date of Electronic Publication: 2025 May 21.
Publication Type: Journal Article; Clinical Trial Protocol; Research Support, N.I.H., Extramural
Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE
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  Data: Evaluating brain mechanisms of combined vagus nerve stimulation and mindfulness training for migraine: A randomized 2 × 2 factorial clinical trial protocol.
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  Data: <searchLink fieldCode="AU" term="%22Schuman-Olivier+Z%22">Schuman-Olivier Z</searchLink>; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA. Electronic address: zschuman@cha.harvard.edu.<br /><searchLink fieldCode="AU" term="%22Marin+F%22">Marin F</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Kinder+LD%22">Kinder LD</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Datko+M%22">Datko M</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Round+K%22">Round K</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Center for Mindfulness and Compassion, Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Tohyama+S%22">Tohyama S</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Garcia+RG%22">Garcia RG</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; School of Medicine, Universidad de Santander, Bucaramanga, Colombia.<br /><searchLink fieldCode="AU" term="%22Hirschtick+RL%22">Hirschtick RL</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Edwards+RR%22">Edwards RR</searchLink>; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Wells+RE%22">Wells RE</searchLink>; Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, NC, USA.<br /><searchLink fieldCode="AU" term="%22Cheng+HT%22">Cheng HT</searchLink>; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Barbieri+R%22">Barbieri R</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Hadjikhani+N%22">Hadjikhani N</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Loggia+ML%22">Loggia ML</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Kaptchuk+TJ%22">Kaptchuk TJ</searchLink>; Department of Medicine, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Houle+TT%22">Houle TT</searchLink>; Department of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Rosen+BR%22">Rosen BR</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Napadow+V%22">Napadow V</searchLink>; Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
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  Data: <searchLink fieldCode="JN" term="%22101242342%22">Contemporary clinical trials</searchLink> [Contemp Clin Trials] 2025 Jul; Vol. 154, pp. 107947. <i>Date of Electronic Publication: </i>2025 May 21.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101242342 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1559-2030 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215517144%22">15517144 </searchLink><i>NLM ISO Abbreviation: </i>Contemp Clin Trials <i>Subsets: </i>MEDLINE
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